Download PHASE II STUDY OF NEO-ADJUVANT PACLITAXEL

CALGB 99811
Southeast Cancer Control Consortium Consent Form
Phase II Study of Neo-adjuvant Paclitaxel, Estramustine, And Carboplatin
(TEC) plus Androgen Ablation Prior to Radiation Therapy in Patients with
Poor Prognosis Localized Prostate Cancer
What Is A Research Study?
This is a clinical trial (a type of research study). Clinical trials include only patients who
choose to take part. Please take your time to make your decision. Discuss it with your
friends and family. You may request a copy of the NCI booklet "Taking Part in Clinical Trials:
What Cancer Patients Need To Know".
You are being asked to take part in this study because you have prostate cancer and
have a risk of not having the cancer controlled with radiation therapy.
Why Is This Study Being Done?
We know the majority of patients with your stage of prostate cancer, based on your blood
tests, the biopsy of the prostate, and x-rays, will have the cancer return when radiation
therapy is used by itself. The addition of drugs that lower the male hormone testosterone
before and after radiation therapy has improved the results of the radiation therapy but in
over half of the cases the cancer will still return within 5 years. This study will study the
effects (good and bad) that the addition of chemotherapy drugs to the hormone treatment
and radiation treatment has on you and your prostate cancer.
How Many People Will Take Part In The Study?
About 60 men will take part in this study.
What Is Involved In The Study?
If you decide to take part in this study, you will receive three different kinds of treatment:
hormone treatment, chemotherapy, and radiation therapy.
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The hormone treatment consists of a shot called Lupron® or Zoladex®. The shot will be
given in the muscle or in the fatty tissue. This will be given once a month for six months.
The chemotherapy will consist of three drugs. One is a pill called estramustine phosphate
(Emcyt®). You take two pills three times a day five out of seven days a week. The two
other chemotherapy drugs are each given through the vein (intravenously) over 1 hour. One
is called paclitaxel and is given once a week. The other is carboplatin and is given once
every four weeks after the paclitaxel. All chemotherapy will be given for four months, then
stopped.
At the end of the four months of chemotherapy, you will have approximately eight weeks
(2 months) of radiation therapy to the prostate. The radiation therapy will be given 5 days a
week, Monday through Friday, for 8 weeks.
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CALGB 99811
Southeast Cancer Control Consortium Consent Form
During the chemotherapy and radiotherapy, your red bloods cells may decrease and you
may become tired. If this does occur, you will be started on a medication called epoetin
alpha (Procrit®). This will increase your red blood cells and may make you feel less
fatigued.
One of the chemotherapy drugs, estramustine phosphate, can cause blood clots. To help
prevent blood clots, you will be given a drug called Coumadin® to thin your blood.
During the time that you are taking estramustine phosphate, you will be asked to avoid
milk, milk products, and calcium-containing preparations from 2 hours before until 1 hour
after taking the drug.
During participation in this study, you should also avoid taking saw palmetto or large
quantities of vitamins.
Treatment Schedule:
Hormone
Therapy
Paclitaxel
Cycle 1:
Weeks 1-4
X
Cycle 2:
Weeks 5-8
X
Cycle 3:
Weeks 9-12
X
Cycle 4:
Weeks 13-16
X
W
W
W
W
W
W
W
W
W
W
W
W W
W W W
Estramustine
D
D
D
D
D
D
D
D
D
D
D
D
D
Carboplatin
X
X
X
Radiation
Therapy
D
Cycle 5:
Weeks 17-20
X
Cycle 6:
Weeks 21-24
X
D D
X
D D
D
D
D D
W = Weekly
D = Daily, for 5 out of 7 days per week
One cycle of chemotherapy = 4 weeks of treatment.
Once you complete the chemotherapy and radiation therapy, you will be monitored with
blood tests, digital rectal exams, and x-rays. You will initially be seen every 3 months for
the first two years, then every 6 months for four years. You will also be asked to undergo
another biopsy of the prostate in 30 to 36 months (2 1/2 to 3 years) after you completed
the radiation therapy or any time it appears that the cancer is coming back. This is to see
if the cancer is in the prostate or outside the prostate.
Procedures that are part of regular cancer care and may be done even if you do not join
the study.
 Complete blood count, serum chemistry, liver function tests, and PSA tests.
 Biopsy, CT scan, and bone scan.
Standard procedure being done because you are in this study.
 Complete blood counts and chemistry, liver function tests, PSA tests, and urinalysis.
 Serum testosterone.
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Participant Initials ______
D
D
CALGB 99811
Southeast Cancer Control Consortium Consent Form
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Serial CT scan and bone scan to monitor disease.
Second biopsy.
How Long Will I Be In The Study?
Your treatment should take about six months to complete. We will ask that you return for
monitoring visits every 3 to 4 months for six years after the start of the treatment.
The researcher may decide to take you off this study if: 1) continued participation is
deemed not in your best medical interest, 2), health conditions occur which would make
your participation possibly dangerous 3), new information becomes available.
You can stop participating at any time. However, if you decide to stop participating in the
study, we encourage you to talk to the researcher and your regular doctor first.
What Are The Risks Of The Study?
While on the study, you are at risk for these side effects. You should discuss these with
the researcher and/or your regular doctor. There also may be other side effects that we
cannot predict or are unforeseen or unexpected. Other drugs will be given to make side effects
less serious and uncomfortable. Many side effects go away shortly after the chemotherapy is
stopped, but in some cases, the side effects can be serious, long lasting or permanent.
Very Likely:
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Mouth and throat sores
Diarrhea
Nausea and vomiting
Hair loss
Fluid retention/edema
Confusion
A temporary decrease in numbers of white blood cells, red blood cells, and platelets
Loss of appetite
Hot flashes
Redding of the skin
Less Likely:
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Liver irritation
Fatigue
Headache
Jaw pain
Muscle weakness
Hallucinations
Insomnia (inability to sleep)
Constipation
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Participant Initials ______
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CALGB 99811
Southeast Cancer Control Consortium Consent Form
Indigestion
Chest pain
Decreased sex drive
Difficulty urinating
Breast tenderness or breast enlargement
Inflammation of the bladder with blood in the urine and burning while urinating
Unsteadiness when walking
Decreased hearing
Tingling of fingers and toes
Loss of reflexes
Blurred vision
Redness and swelling of veins
Skin ulcer
Abnormal liver tests
Increased blood pressure
High red blood cell count
Decreased ability to have erections
Swelling of the genitals or legs
Unlikely But Serious:
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Convulsions (seizures)
Stroke
Heart attack
Kidney damage
Allergic reaction
Rectal bleeding
Heart failure causing fluid in the lungs
Abnormal formation of blood clots
Small bowel obstruction
Inflammation of the rectum
Severe blistering of the skin
Death
Secondary malignancies: A number of established chemotherapeutic drugs have an
inherent (basic) risk of causing secondary cancers and/or leukemias. Certain drugs in use today,
not currently known to be associated with this risk, may be shown at a later time to result in the
development of these secondary cancers and/or leukemias.
Unanticipated side effects may occur which have not been reported. If you have any
unusual symptoms, report them immediately to your doctor.
Reproductive risks (Birth Control): Due to the unknown effects of this treatment on unborn
babies, you must use an adequate form of birth control. If a man fathers a child, there may be
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Participant Initials ______
CALGB 99811
Southeast Cancer Control Consortium Consent Form
potential risk to the unborn baby; therefore female sexual partners of men on treatment should
use an adequate form of birth control. Reliable methods of birth control are considered to be:
abstinence (not having sex), oral contraceptives, Intrauterine Device (IUD), DepoProvera,
Norplant, tubal ligation or hysterectomy of the partner. An acceptable, although less reliable
method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or
sponge. We encourage you to discuss this issue further with your doctors if you have any
questions.
For more information about risks and side effects, ask the researcher or contact your local
doctor.
Will I Benefit From Taking Part in the Study?
If you agree to take part in this study, there may or may not be direct medical benefit to you. We
hope that information learned from this study will benefit other patients with prostate cancer in
the future.
What Other Options Are Available?
Instead of being in this study, you have these options:
 Hormone treatment without the radiation therapy,
 In some cases, surgical resection of the prostate.
 No treatment at this time with care to help you feel more comfortable.
Please talk to your regular doctor about these and other options.
What About Confidentiality?
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute
confidentiality. Your personal information may be disclosed if required by law.
A record of your progress will be kept in a confidential form at your hospital or doctor’s office
where you receive treatment. Organizations that may inspect and/or copy your research records
(blood samples, x-rays, scans, and pathology slides) for quality assurance and data analysis include
groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Cancer and Leukemia Group B (CALGB)
Quality Assurance Review Center (QARC)
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
Possible other federal or state government agencies
If your record is used or given out for governmental purposes, it will be done under conditions that
will protect your privacy to the fullest extent possible consistent with laws relating to public
disclosure of information and law-enforcement responsibilities of the agency.
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Participant Initials ______
CALGB 99811
Southeast Cancer Control Consortium Consent Form
You authorize the use of clinical information contained in your records, but any publication which
includes such information or data shall not reveal your name, show your picture or contain any
other personally identifying information, except as otherwise required by law.
What Are The Costs?
Taking part in this study may lead to added costs to you or your insurance company. You or your
insurance carrier will be responsible for the costs of clinic visits, any hospital admissions,
laboratory tests, x-rays, scans, chemotherapy treatments, radiation therapy treatments, and any
other tests. Please ask your doctor about any added costs or insurance problems. You will not be
paid to participate in this study.
In the case of injury or illness resulting from this study, emergency medical treatment is available
but will be provided at the usual charge. No funds or monies have been set aside to compensate
you in the event of injury.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
What Are My Rights As A Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the study
at any time but we encourage you to talk to your doctor first. Leaving the study will not result in
any penalty or loss of benefits to which you are entitled. If you withdraw from the study, you will
continue to be followed and clinical data will be collected from your medical records. You are
free to seek care from a doctor of your choice at any time.
We will tell you about new information that may affect your health, welfare, or willingness
to stay in this study.
Who Do I Call If I Have Questions Or Problems?
For questions about the study or a research-related injury, contact your doctor, _______________,
at # _______________. You may ask your doctor for further information on the risks, benefits or
alternative treatments.
For questions about your rights as a research participant, contact the __________________
Institutional Review Board (which is a group of people at the hospital in the community where
you receive treatment who review the research to protect your rights) at # ________________ (the
office of _______________________).
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Participant Initials ______
CALGB 99811
Southeast Cancer Control Consortium Consent Form
Where Can I Get More Information?
6/02
You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or
TTY: 1-800-332-8615 or you may visit the Cancer Information Service Website:
http://www.cancer.gov/cis
You may visit the NCI’s Web site:
http://www.cancer.gov
This website contains comprehensive clinical trials information and accurate cancer information.
Participant Contract
I have been offered the opportunity to ask questions about this study and all questions have been
answered to my satisfaction. The contents of this form have been explained to me and I
understand them. I agree to allow the research personnel specified above the access to my medical
records.
It may be necessary for my doctor to contact me at a future date regarding new information about
the treatment I received, therefore I agree to notify my doctor of any change of address and/or
telephone number.
My signature below means that I have voluntarily agreed to participate in this research study. A
copy of this consent form has been given to me. I may also request a copy of the research study
(complete study plan).
_______________________
_____________________________________________
(Date)
(Participant Signature)
_____________________
(Date)
_____________________________________________
(Witness Signature)
I certify that I have explained to the above individual the nature and purpose, the potential benefits,
and possible risks associated with participation in the research study and have answered any
questions that have been raised.
__________________
(Date)
______________________________________
(Provider of Information Signature)
__________________
(Date)
______________________________________
(Provider of Information Signature)
(If applicable for second provider)
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CALGB 99811
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on CALGB 99811.
Even though I withdraw my consent for treatment, I will continue to be followed and clinical data
will be collected from my medical records.
Participant Name __________________________ CALGB ID Number ___________________
(Please Print Name)
Participant Signature _________________________________
Date _______________
Witness Signature ___________________________________
Date _______________
5/15/01
CALGB 99811
Southeast Cancer Control Consortium Withdrawal of Consent
I, __________________________ , withdraw my consent to participate in CALGB 99811 and
refuse to be followed and have clinical data collected from my medical records.
Participant Name __________________________ CALGB ID Number ___________________
(Please Print Name)
Participant Signature _________________________________
Date _______________
Witness Signature ___________________________________
Date _______________
5/15/01